Stretch Valve Balloon Catheter and Methods for Producing and Using Same

Abstract

A safety balloon catheter includes a stretch valve and a balloon catheter having a proximal catheter end, a balloon defining an interior to be inflated with an inflation fluid, an inflation lumen extending through the shaft to the interior and shaped to convey inflation fluid thereto and from, a second lumen parallel to the inflation lumen, and a balloon drainage port fluidically connecting the balloon interior to the second lumen. The hollow stretch valve is shaped to permit a fluid to pass therethrough and is positioned in the second lumen to at least partially slide therein such that, in a steady state, the stretch valve prevents the inflation fluid from passing through the drainage port and, in an over-inflated state, the distal sliding portion slides within the second lumen to permit the inflation fluid to pass through the drainage port and into the second lumen.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application:[0002]claims the priority, under 35 U.S.C. §119, of copending U.S. Provisional Patent Application No. 61 / 637,690, filed Apr. 24, 2012;[0003]is a continuation-in-part of U.S. patent application Ser. No. 11 / 339,258, filed Jan. 25, 2006, now U.S. Pat. No. 7,883,503 (which application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Nos. 60 / 647,204 and 60 / 647,205, both filed Jan. 26, 2005);[0004]is a continuation-in-part of U.S. patent application Ser. No. 12 / 943,453, filed Nov. 10, 2010 (which application claims the benefit under 35 U.S.C. §119(e) of U.S. provisional application No. 61 / 260,271 filed Nov. 11, 2009);[0005]is a continuation-in-part of U.S. patent application Ser. No. 13 / 707,952, filed Dec. 7, 2012 (which application claims the benefit under 35 U.S.C. §119(e) of U.S. provisional application No. 61 / 637,690, filed Apr. 24, 2012);[0006]is a continuation-in-part of U.S. patent applic...

AI Technical Summary

Benefits of technology

The present invention is a low-pressure balloon catheter with a safety feature that prevents injury during use. The balloon automatically deflates before an injury can occur, such as when being forced to withdraw from the bladder or inflating within a ureter. The safety catheter is unique because the inflation fluid has the opportunity to exit the balloon and inform the user or health-care professional of a dangerous condition, such as if the balloon is inflated within a constricted lumen or if the catheter is stretched enough to cause the stretch-valve of the inserted balloon to act and prevent possible pull-out injury. The inflation fluid will show visually and immediately that an attempt has been made to inflate the balloon or that the catheter has been stretched enough to cause the stretch-valve of the inserted balloon to act and prevent possible pull-out injury. This feature prevents injury and allows for corrective action to be taken before further injury occurs. The invention provides a safer and effective tool for medical use.

Problems solved by technology

Prior art urinary catheters are not constructed to prevent tearing of the urethra during a catheter implanting procedure and are not constructed to break in any predefined way.

These complications are responsible for increases in hospital stays, excessive bleeding, mortality, as well as morbidity.

They also cause an increased expense and burden on the already-stressed health care system.

First, and probably most common, is improper placement of the catheter.

Because of the unique anatomy of the male urethra, placing a urethral catheter for urinary drainage can be difficult.

A problem arises when the physician, technician, or nurse thinks that the catheter is actually in a proper position when it is not.

Therefore, if the balloon catheter is not inserted far enough, inflation of the balloon 3 will cause serious injury to the urethra 10.

Both of these improper insertions cause severe bleeding and damage.

Tearing of the urethra 10 in this way causes bleeding and allows bacteria to enter into the bloodstream at the tear site, thus causing the subsequent bladder infection and, eventually, sepsis.

Significant bleeding can become life threatening.

Also, without sufficient and immediate venting of the balloon inflation fluid after improper placement, an accidental or intentional pull on the catheter externally can and does cause extensive bodily harm to the patient.

Life threatening bleeds, especially in patients who are anticoagulated, can and do occur.

Also, when the urine is infected, as in immunocompromised patients and the elderly, the bacteria enter the blood stream and can cause serious infections (e.g., sepsis), which frequently can lead to death.

If the patient survives the initial trauma, then long-term complications, such as strictures, can and usually do occur.

Strictures cause narrowings within the urine channel and usually require additional procedures and surgeries to correct.

The tubing may inadvertently become fixed while the patient is still moving, at which time a sudden jerk is imparted upon the balloon and pulls the balloon into the urethra, which tears the urethra, causing severe pain and bleeding.

Hundreds of thousands of such iatrogenic injuries occur each year—all of which need to be prevented, not only for patient safety, but also because the cost imposed on the medical health industry for each injury is enormous.

Yet another scenario occurs when the patient deliberately pulls on the catheter, thereby causing self-induced pain and injury to the urethra.

During the spasm, the confused patient often tugs and pulls on a catheter, which results in injury.

Under such circumstances, insurance typically does not cover the resulting extensive medical expenses.

The injuries mentioned herein are not limited to males and also cause severe damage to the female bladder and urethra.

The injuries can also occur post-surgically, which makes the damage even more severe.

One common situation where injury is caused is when the patient is medicated with morphine or other analgesics that render the patient confused and unable to make rational decisions.

However, once the urethra is torn, replacing the damaged catheter with another catheter is quite difficult and, in fact, exacerbates the injury.

But, these advances do nothing to prevent the injuries explained herein.

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